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Niraparib tosylate - Generic Drug Details
What are the generic drug sources for niraparib tosylate and what is the scope of patent protection?
Niraparib tosylate
is the generic ingredient in one branded drug marketed by Tesaro Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Niraparib tosylate has two hundred and thirty-nine patent family members in forty-nine countries.
Summary for niraparib tosylate
| International Patents: | 239 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 1 |
| Patent Applications: | 7 |
| DailyMed Link: | niraparib tosylate at DailyMed |
Recent Clinical Trials for niraparib tosylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| University of California, Davis | Phase 2 |
| Janssen, LP | Phase 2 |
Synonyms for niraparib tosylate
| (S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide 4-?methylbenzenesulfona?te |
| (S)-2-(4-(Piperidin-3-yl)phenyl)-2H-indazole-7-carboxamide 4-methylbenzenesulfonate |
| 1038915-73-9 |
| 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide; 4-methylbenzene-1-sulfonic acid |
| 2H-Indazole-7-carboxamide, 2-(4-(3S)-3-piperidinylphenyl)-, 4-methylbenzenesulfonate (1:1) |
| 75KE12AY9U |
| AC-30383 |
| AS-56981 |
| AX8326059 |
| CS-2283 |
| HY-10619B |
| KS-00000TSH |
| MK 4827 tosylate |
| MK-4827 (tosylate) |
| MK-4827 tosylate |
| mk-4827-niraparib-tosylate |
| MK-4827-tosylate |
| MK-4827(Niraparib) tosylate |
| Niraparib (MK-4827) tosylate |
| Niraparib tosylate, MK 4827 tosylate |
| Niraparib; 4-methylbenzene-1-sulfonic acid |
| Niraparib(MK-4827) tosylate |
| Q27266392 |
| s7625 |
| SB16549 |
| SCHEMBL20522624 |
| UNII-75KE12AY9U |
US Patents and Regulatory Information for niraparib tosylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tesaro Inc | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tesaro Inc | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tesaro Inc | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tesaro Inc | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tesaro Inc | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for niraparib tosylate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2547077 | Start Trial |
| European Patent Office | 1684736 | Start Trial |
| Portugal | 2805945 | Start Trial |
| China | 102935230 | Start Trial |
| Croatia | P20190972 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for niraparib tosylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | C01633724/01 | Switzerland | Start Trial | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016 |
| 2109608 | 2018/019 | Ireland | Start Trial | PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE.; REGISTRATION NO/DATE: EU/1/17/1235 20171116 |
| 2109608 | LUC00072 | Luxembourg | Start Trial | PRODUCT NAME: NIRAPARIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, STEREOISOMERE OU TAUTOMERE DE CELUI-CI, NOTAMMENT LE TOSYLATE OU UN HYDRATE, PARTICULIEREMENT LE TOSYLATE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120 |
| 2109608 | 2018016 | Norway | Start Trial | PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127 |
| 1633724 | PA2015016,C1633724 | Lithuania | Start Trial | PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
